Status:
COMPLETED
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Lead Sponsor:
AlloSource
Conditions:
Degenerative Osteoarthritis
Post-traumatic; Arthrosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixat...
Eligibility Criteria
Inclusion
- Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
- Patients must be able to attend follow-up examinations for the duration of the trial.
- The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion
- Younger than 18 years old or older than 80 years old.
- Has a condition that prevents ambulation or completion of any of the trial measurements.
- Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary.
- Has treatment planned for the arthrodesis which does not require the use of screws.
- Has any active infection of the hindfoot, a systemic infection or bacteremia.
- Has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\].
- Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01413061
Start Date
June 1 2010
End Date
March 1 2018
Last Update
April 13 2018
Active Locations (5)
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1
Institute for Foot and Ankle Reconstruction at Mercy
Baltimore, Maryland, United States, 21202
2
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States, 49525
3
Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Edina, Minnesota, United States, 55435
4
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033